Feasibility and Preliminary Efficacy of Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Single-Arm National Pilot Study.

Background: Approximately 45% of individuals taking methadone or buprenorphine have chronic pain. These medications are commonly prescribed for chronic pain or opioid use disorder (OUD). To optimize pain management as well as reduce opioid-related symptoms (eg, craving) and risks (misuse and overdose), there is a critical need for a brief, effective, and accessible pain skills intervention for this population. Objective: This single-arm study aimed to examine the feasibility and preliminary efficacy of online Empowered Relief (ER), a 1-session pain relief skills class, for individuals with chronic pain taking methadone or buprenorphine for chronic pain or OUD. Methods: A priori feasibility criteria were defined as at least 75% of enrolled participants attending the ER class and the mean satisfaction rating of at least 8 on a 0-10 scale. Participants were recruited nationally across the United States. Out of the 69 enrolled participants, 55 attended the ER class. Self-report measures were collected at baseline, immediately post class, and at follow-up points of 2 weeks and months 1-3. Additionally, qualitative interviews were conducted in a small sample (n=14) to obtain in-depth participant feedback. Among the class attendees, 51 participants (27/51, 52.9% female; mean age 48.6, SD 12.2, range 28-71 years) completed at least one follow-up survey, and treatment outcomes were analyzed using repeated measures ANOVA, with missing data imputed using linear regression. This analytic sample consisted of 24 participants taking methadone and 27 participants taking buprenorphine; 43.1% (22/51) endorsed at least≥2 OUD symptoms within the past 12 months, meeting the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]) diagnostic criteria for current OUD. Results: Feasibility was achieved with 79.7% (55/74) attendance and mean 8.6 (SD 2) ratings of treatment appraisal and satisfaction. Qualitative feedback demonstrated high acceptability of the class content and delivery, with suggestions for refinements. Repeated-measures ANOVAs and FDR-corrected post hoc tests revealed significant reductions at 1 month post-ER class (primary endpoint) in pain intensity (Cohen d=0.71), pain bothersomeness (Cohen d=0.54), and pain interference (Cohen d=0.61). At 3 months post-ER class, efficacy was maintained for pain intensity, pain bothersomeness, and pain interference (Cohen d=0.28, 0.44, and 0.48, respectively). No significant time effects were observed for pain catastrophizing, sleep disturbance, physical function, fatigue, depression, anxiety, social isolation, and opioid craving. Conclusions: This study is the first to test ER in patients taking methadone or buprenorphine for pain or OUD. Findings showed feasibility, acceptability, and preliminary evidence of treatment efficacy. Participant feedback will inform future study designs. These findings support a randomized trial to fully evaluate the efficacy and scalability of ER in this population.